Status not kept up to date
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
NCT06032572 · Shenzhen Raysight Intelligent Medical Technology Co., Ltd. · Updated 13 Sept 2023
- What is being tested
- VRS100 robotic-assisted PCI; Manual PCI
- For
- Coronary Artery Disease; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Vascular Disease Occlusive
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 204 people. The full rules are on the registry page.
- Where
- China (3 sites)
- When
- Starts or started 8 Sept 2023, ends 1 Aug 2024. Registered 13 Sept 2023.
- Results
- None posted yet.
In the researchers' words
The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI).
Sites
- Shenzhen People's HospitalShenzhen, Guangdong, China
- Zhongshan HospitalShanghai, Shanghai Municipality, China
- West China Hospital of Sichuan UniversityChengdu, Sichuang, China